FDA 510(k)

HyperLight 便携式X射线单元

K号: K232068 · 2023-09-01

申请人Changzhou Sifary Medical Technology Co., Ltd.

决定日期2023-09-01

产品代码EHD

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决定实质等同

器械摘要

HyperLight Portable X-ray Unit is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232068. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HyperLight Portable X-ray Unit?

HyperLight Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K232068.

When did HyperLight Portable X-ray Unit receive FDA 510(k) clearance?

HyperLight Portable X-ray Unit received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232068.

Who is the listed applicant for HyperLight Portable X-ray Unit?

FDA 510(k)记录将常州思法瑞医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for HyperLight Portable X-ray Unit?

The FDA product code for HyperLight Portable X-ray Unit is EHD.

列明Changzhou Sifary Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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